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| ID | Type | Description | Link |
|---|---|---|---|
| I5Q-MC-CGAG | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with episodic migraine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Galcanezumab 120mg | Experimental | Galcanezumab given by subcutaneous (SC) injection at 120mg dose once a month for 6 months. Participants received a loading dose of 240mg (2 injections of 120mg each) was administered at visit 3 only. |
|
| Galcanezumab 240mg | Experimental | Galcanezumab 240mg given by SC injection once a month for 6 months. |
|
| Placebo | Placebo Comparator | Placebo given by SC injection once a month for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galcanezumab | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days | Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred. Migraine Headache : A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B): A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia; Overall mean is derived from the average of months 1 to 6 from mixed model repeated measures (MMRM) model. Least Square (LS) mean was calculated using mixed model repeated measures (MMRM) model with treatment, pooled country, month, and treatment by month, baseline, and baseline by month as fixed effects. | Baseline, Month 1 through Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days | Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. Mean is derived from the average of months 1 to 6 from generalized linear mixed model repeated measures. Mean percentages of participants were calculated with a generalized linear mixed model repeated measures method with treatment, month and treatment by month, baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Territory Neurology & Research Institute | Tucson | Arizona | 85704 | United States | ||
| Orange Grove Family Practice |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35076090 | Derived | Ailani J, Kuruppu DK, Rettiganti M, Oakes T, Schroeder K, Wietecha L, Port M, Blumenfeld AM. Does "wearing off" of efficacy occur in galcanezumab-treated patients at the end of the monthly treatment cycle? Post hoc analyses of four phase III randomized trials. Headache. 2022 Feb;62(2):198-207. doi: 10.1111/head.14257. Epub 2022 Jan 25. | |
| 34264500 |
| Label | URL |
|---|---|
| Click here for more information about this study: Evaluation of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-1 Study | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants (pts) received placebo by subcutaneous injection once a month for 6 months. Participants did not receive any intervention during post-treatment follow-up phase. |
| FG001 | Galcanezumab 120mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double Blind Treatment Phase |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 23, 2015 | Oct 4, 2018 |
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| Placebo | Drug | Administered SC |
|
| Baseline, Month 1 through Month 6 |
| Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 (v2.1) Role Function Restrictive Domain | MSQ v2.1 was developed to address physical & emotional limitations of specific concern to individuals with migraine. It consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6), & are reverse-recoded (value 6 to 1) before the domain scores are calculated.Total raw scores for each domain is the sum of the final item value for all of the items in that domain.After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement. Mean is derived from the average of months 4 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline by month & baseline MHD category as fixed factors. | Baseline, Month 4 through Month 6 |
| Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache | Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed effects. | Baseline, Month 1 through Month 6 |
| Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Rating | The PGI-S scale is a patient-rated instrument that measures patients own global impression of their illness severity. The patient was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options were from 1 ("normal, not at all ill") to 7 ("extremely ill"). Mean is derived from the average of months 4 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors. | Baseline, Month 4 through Month 6 |
| Overall Mean Change From Baseline in Headache Hours | Headache Hours is calculated as the total number of headache hours on which a headache occurred. Overall mean is derived from the average of months 1 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month and baseline MHD category. | Baseline, Month 1 through Month 6 |
| Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score | The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors. | Baseline, Month 6 |
| Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab | Treatment emergent (TE) ADA evaluable participant is considered to be TE ADA+ if the subject has at least one post-baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post-baseline result of ADA present with titer >= 1: 20. | Month 1 through Month 6 |
| Pharmacokinetics (PK): Serum Concentrations of Galcanezumab | Pharmacokinetics (PK): Serum Concentrations of Galcanezumab. | Month 6 |
| Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) | Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP). | Month 6 |
| Tucson |
| Arizona |
| 85741 |
| United States |
| Arkansas Clinical Research | Little Rock | Arkansas | 72205 | United States |
| Advanced Clinical Research | Carmichael | California | 95608 | United States |
| Pharmacology Research Institute, Newport Beach | Encino | California | 91316 | United States |
| Tooraj Joseph Raoof M.D., Inc. | Encino | California | 91436 | United States |
| Fullerton Neurology and Headache Center | Fullerton | California | 92835 | United States |
| Sun Valley Research Center | Imperial | California | 92251 | United States |
| Irvine Clinical Research Center | Irvine | California | 92618 | United States |
| Pharmacology Research Institute, Newport Beach | Los Alamitos | California | 90720 | United States |
| Pharmacology Research Institute, Newport Beach | Newport Beach | California | 92660 | United States |
| Desert Valley Research | Rancho Mirage | California | 92270 | United States |
| Anderson Clinical Research | Redlands | California | 92374 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| Medical Center for Clinical Research | San Diego | California | 92108 | United States |
| Alpine Clinical Research Center | Boulder | Colorado | 80301 | United States |
| MCB Clinical Research Centers | Colorado Springs | Colorado | 80910 | United States |
| Mile High Research Center | Denver | Colorado | 80218 | United States |
| Colorado Neurological Institute | Englewood | Colorado | 80113 | United States |
| Advanced Neurosciences Research, LLC | Fort Collins | Colorado | 80528 | United States |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | United States |
| Meridien Research | Bradenton | Florida | 34201 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| Suncoast Clinical Research | New Port Richey | Florida | 34652 | United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| Sensible Healthcare | Ocoee | Florida | 34761 | United States |
| Psychiatric Inst of Florida-Clinical Neuroscience Solutions | Orlando | Florida | 32801 | United States |
| Compass Research | Oviedo | Florida | 32765 | United States |
| Accord Clinical Research, LLC | Port Orange | Florida | 32129 | United States |
| Roskamp Institute | Sarasota | Florida | 34243 | United States |
| Infinity Clinical Reserach . LLC | Sunrise | Florida | 33351 | United States |
| Premiere Research Institute at Palm Beach Neurology | West Palm Beach | Florida | 33407 | United States |
| Advanced Clinical Research LLC | Meridian | Idaho | 83642 | United States |
| Healthcare Research Network - Blue Island | Blue Island | Illinois | 60406 | United States |
| Community Clinical Research Center | Anderson | Indiana | 46011 | United States |
| Investigative Clinical Research of Indiana, LLC | Elwood | Indiana | 46036 | United States |
| Midwest Institute for Clinical Research | Indianapolis | Indiana | 46260 | United States |
| Deaconess Clinic Inc | Newburgh | Indiana | 47630 | United States |
| Integrated Clinical Trial Services, Inc. | West Des Moines | Iowa | 50265 | United States |
| Phoenix Medical Research, Inc | Prairie Village | Kansas | 66206 | United States |
| Otri-Med Corporation | Edgewood | Kentucky | 41017 | United States |
| L-Marc Research Center | Louisville | Kentucky | 40213 | United States |
| PharmaSite Research Inc | Baltimore | Maryland | 21208 | United States |
| Boston Clinical Trials Inc | Boston | Massachusetts | 02131 | United States |
| Michigan Head, Pain and Neurological Institute | Ann Arbor | Michigan | 48104 | United States |
| Clinical Research Institute | Minneapolis | Minnesota | 55402 | United States |
| ClinVest | Springfield | Missouri | 65807 | United States |
| Healthy Perspectives Innovative Mental Health Services, PL | Nashua | New Hampshire | 03060 | United States |
| Albuquerque Clinical Trials | Albuquerque | New Mexico | 87102 | United States |
| Dent Neurological Institute | Amherst | New York | 14226 | United States |
| Central New York Clinical Research | Manlius | New York | 13104 | United States |
| NYU Langone | New York | New York | 10016 | United States |
| Fieve Clincial Services | New York | New York | 10168 | United States |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | United States |
| Metrolina Neurological Associates, PA | Charlotte | North Carolina | 28210 | United States |
| Headache Wellness Center | Greensboro | North Carolina | 27405 | United States |
| Rapid Medical Research Inc | Cleveland | Ohio | 44122 | United States |
| Medical College of Ohio at Toledo | Toledo | Ohio | 43614 | United States |
| Healthcare Research Consultant | Tulsa | Oklahoma | 74135 | United States |
| Summit Research Network Inc | Portland | Oregon | 97210 | United States |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18104 | United States |
| Preferred Primary Care Physicians | Pittsburgh | Pennsylvania | 15236 | United States |
| Abington Neurological Associates | Willow Grove | Pennsylvania | 19090 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| Clinical Trials of South Carolina | Charleston | South Carolina | 29406 | United States |
| 8 Medical Park | Columbia | South Carolina | 29203 | United States |
| ClinSearch | Chattanooga | Tennessee | 37421 | United States |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | United States |
| Clinical Research Associates | Nashville | Tennessee | 37203 | United States |
| FutureSearch Trials | Austin | Texas | 78731 | United States |
| Protenium Clinical Research | Hurst | Texas | 76054 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Radiant Research - San Antonio | San Antonio | Texas | 78229 | United States |
| Advanced Clinical Research | West Jordan | Utah | 84088 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | United States |
| Clinical Research Associates of Tidewater | Norfolk | Virginia | 23507 | United States |
| National Clinical Research - Richmond | Richmond | Virginia | 23294 | United States |
| Premier Clinical Research | Spokane | Washington | 99202 | United States |
| Vancouver Clinic | Vancouver | Washington | 98664 | United States |
| Clinical Investigation Specialists Inc | Kenosha | Wisconsin | 53142 | United States |
| For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Brampton | L6T 0G1 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Kelowna | V1Y 1Z9 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Mississauga | L4Y 2N8 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Montreal | H3A 2B4 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Ottawa | K2G 6E2 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Sherbrooke | J1H1Z1 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Toronto | M9W 4L6 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Vancouver | V6Z 2E8 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Waterloo | N2J 1C4 | Canada |
| Office of Dr. Ruddy Guerra | Manati | 00674 | Puerto Rico |
| NuFrontiers Clinical Research LLC | Rio Piedras | 00923 | Puerto Rico |
| Clinical Research Puerto Rico, Inc. | San Juan | 00909 | Puerto Rico |
| GCM Medical Group PSC | San Juan | 00909 | Puerto Rico |
| Instituto de Neurologia Dra. Ivonne Fraga | San Juan | 00918 | Puerto Rico |
| Neuro GI Wellness Center | San Juan | 00926 | Puerto Rico |
| Citrome L, Sanchez Del Rio M, Dong Y, Nichols RM, Tockhorn-Heidenreich A, Foster SA, Stauffer VL. Benefit-Risk Assessment of Galcanezumab Versus Placebo for the Treatment of Episodic and Chronic Migraine Using the Metrics of Number Needed to Treat and Number Needed to Harm. Adv Ther. 2021 Aug;38(8):4442-4460. doi: 10.1007/s12325-021-01848-x. Epub 2021 Jul 15. |
| 34049484 | Derived | Jedynak J, Eross E, Gendolla A, Rettiganti M, Stauffer VL. Shift from high-frequency to low-frequency episodic migraine in patients treated with Galcanezumab: results from two global randomized clinical trials. J Headache Pain. 2021 May 28;22(1):48. doi: 10.1186/s10194-021-01222-w. |
| 33950375 | Derived | Pozo-Rosich P, Samaan KH, Schwedt TJ, Nicholson RA, Rettiganti M, Pearlman EM. Galcanezumab Provides Consistent Efficacy Throughout the Dosing Interval Among Patients with Episodic and Chronic Migraine: A Post Hoc Analysis. Adv Ther. 2021 Jun;38(6):3154-3165. doi: 10.1007/s12325-021-01708-8. Epub 2021 May 5. |
| 33549036 | Derived | Ament M, Day K, Stauffer VL, Skljarevski V, Rettiganti M, Pearlman E, Aurora SK. Effect of galcanezumab on severity and symptoms of migraine in phase 3 trials in patients with episodic or chronic migraine. J Headache Pain. 2021 Feb 6;22(1):6. doi: 10.1186/s10194-021-01215-9. |
| 33544305 | Derived | Kuruppu DK, North JM, Kovacik AJ, Dong Y, Pearlman EM, Hutchinson SL. Onset, Maintenance, and Cessation of Effect of Galcanezumab for Prevention of Migraine: A Narrative Review of Three Randomized Placebo-Controlled Trials. Adv Ther. 2021 Mar;38(3):1614-1626. doi: 10.1007/s12325-021-01632-x. Epub 2021 Feb 5. |
| 33143451 | Derived | Dodick DW, Doty EG, Aurora SK, Ruff DD, Stauffer VL, Jedynak J, Dong Y, Pearlman EM. Medication overuse in a subgroup analysis of phase 3 placebo-controlled studies of galcanezumab in the prevention of episodic and chronic migraine. Cephalalgia. 2021 Mar;41(3):340-352. doi: 10.1177/0333102420966658. Epub 2020 Nov 3. |
| 33069214 | Derived | Ailani J, Andrews JS, Rettiganti M, Nicholson RA. Impact of galcanezumab on total pain burden: findings from phase 3 randomized, double-blind, placebo-controlled studies in patients with episodic or chronic migraine (EVOLVE-1, EVOLVE-2, and REGAIN trials). J Headache Pain. 2020 Oct 17;21(1):123. doi: 10.1186/s10194-020-01190-7. |
| 32576229 | Derived | Stauffer VL, Turner I, Kemmer P, Kielbasa W, Day K, Port M, Quinlan T, Camporeale A. Effect of age on pharmacokinetics, efficacy, and safety of galcanezumab treatment in adult patients with migraine: results from six phase 2 and phase 3 randomized clinical trials. J Headache Pain. 2020 Jun 23;21(1):79. doi: 10.1186/s10194-020-01148-9. |
| 31952501 | Derived | Bangs ME, Kudrow D, Wang S, Oakes TM, Terwindt GM, Magis D, Yunes-Medina L, Stauffer VL. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies. BMC Neurol. 2020 Jan 17;20(1):25. doi: 10.1186/s12883-020-1609-7. |
| 31482569 | Derived | Kielbasa W, Quinlan T. Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine. J Clin Pharmacol. 2020 Feb;60(2):229-239. doi: 10.1002/jcph.1511. Epub 2019 Sep 4. |
| 31253091 | Derived | Silberstein SD, Stauffer VL, Day KA, Lipsius S, Wilson MC. Galcanezumab in episodic migraine: subgroup analyses of efficacy by high versus low frequency of migraine headaches in phase 3 studies (EVOLVE-1 & EVOLVE-2). J Headache Pain. 2019 Jun 28;20(1):75. doi: 10.1186/s10194-019-1024-x. |
| 30942898 | Derived | Stauffer VL, Wang S, Voulgaropoulos M, Skljarevski V, Kovacik A, Aurora SK. Effect of Galcanezumab Following Treatment Cessation in Patients With Migraine: Results From 2 Randomized Phase 3 Trials. Headache. 2019 Jun;59(6):834-847. doi: 10.1111/head.13508. Epub 2019 Apr 3. |
| 30594122 | Derived | Forderreuther S, Zhang Q, Stauffer VL, Aurora SK, Lainez MJA. Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent: data from the phase 3, randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2, and REGAIN studies. J Headache Pain. 2018 Dec 29;19(1):121. doi: 10.1186/s10194-018-0951-2. |
| 30462830 | Derived | Nichols R, Doty E, Sacco S, Ruff D, Pearlman E, Aurora SK. Analysis of Initial Nonresponders to Galcanezumab in Patients With Episodic or Chronic Migraine: Results From the EVOLVE-1, EVOLVE-2, and REGAIN Randomized, Double-Blind, Placebo-Controlled Studies. Headache. 2019 Feb;59(2):192-204. doi: 10.1111/head.13443. Epub 2018 Nov 21. |
| 29813147 | Derived | Stauffer VL, Dodick DW, Zhang Q, Carter JN, Ailani J, Conley RR. Evaluation of Galcanezumab for the Prevention of Episodic Migraine: The EVOLVE-1 Randomized Clinical Trial. JAMA Neurol. 2018 Sep 1;75(9):1080-1088. doi: 10.1001/jamaneurol.2018.1212. |
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection. Participants did not receive any intervention during post-treatment follow-up phase.
| FG002 | Galcanezumab 240mg | Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months. Participants did not receive any intervention during post-treatment follow-up phase. |
| Received at Least One Dose of Study Drug |
|
| Safety Population |
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| COMPLETED |
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| NOT COMPLETED |
|
|
| Post Treatment Follow-up Phase |
|
|
All randomized participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo by subcutaneous injection once a month for 6 months. Participants did not receive any intervention during post-treatment follow-up phase. |
| BG001 | Galcanezumab 120mg | Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection. Participants did not receive any intervention during post-treatment follow-up phase. |
| BG002 | Galcanezumab 240mg | Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months. Participants did not receive any intervention during post-treatment follow-up phase. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
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| Migraine Headache Days (MHD) per month | Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. | Mean | Standard Deviation | Days per Month |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days | Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred. Migraine Headache : A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B): A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia; Overall mean is derived from the average of months 1 to 6 from mixed model repeated measures (MMRM) model. Least Square (LS) mean was calculated using mixed model repeated measures (MMRM) model with treatment, pooled country, month, and treatment by month, baseline, and baseline by month as fixed effects. | All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value. | Posted | Least Squares Mean | Standard Error | Days | Baseline, Month 1 through Month 6 |
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| Secondary | Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days | Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. Mean is derived from the average of months 1 to 6 from generalized linear mixed model repeated measures. Mean percentages of participants were calculated with a generalized linear mixed model repeated measures method with treatment, month and treatment by month, baseline. | All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value. | Posted | Mean | Standard Error | percentage of participants | Baseline, Month 1 through Month 6 |
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| Secondary | Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 (v2.1) Role Function Restrictive Domain | MSQ v2.1 was developed to address physical & emotional limitations of specific concern to individuals with migraine. It consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6), & are reverse-recoded (value 6 to 1) before the domain scores are calculated.Total raw scores for each domain is the sum of the final item value for all of the items in that domain.After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement. Mean is derived from the average of months 4 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline by month & baseline MHD category as fixed factors. | All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 4 through Month 6 |
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| Secondary | Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache | Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed effects. | All randomized participants who received at least one dose of study drug and had baseline and post baseline value. | Posted | Least Squares Mean | Standard Error | Days | Baseline, Month 1 through Month 6 |
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| Secondary | Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Rating | The PGI-S scale is a patient-rated instrument that measures patients own global impression of their illness severity. The patient was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options were from 1 ("normal, not at all ill") to 7 ("extremely ill"). Mean is derived from the average of months 4 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors. | All randomized participants who received at least one dose of study drug and had baseline and post baseline value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 4 through Month 6 |
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| Secondary | Overall Mean Change From Baseline in Headache Hours | Headache Hours is calculated as the total number of headache hours on which a headache occurred. Overall mean is derived from the average of months 1 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month and baseline MHD category. | All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value. | Posted | Least Squares Mean | Standard Error | Hours per Month | Baseline, Month 1 through Month 6 |
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| Secondary | Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score | The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors. | All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 6 |
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| Secondary | Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab | Treatment emergent (TE) ADA evaluable participant is considered to be TE ADA+ if the subject has at least one post-baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post-baseline result of ADA present with titer >= 1: 20. | All randomized participants who received at least one dose of study drug and had least one non-missing test result for ADA for each of the baseline period and the post-baseline period. | Posted | Number | percentage of participants | Month 1 through Month 6 |
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| Secondary | Pharmacokinetics (PK): Serum Concentrations of Galcanezumab | Pharmacokinetics (PK): Serum Concentrations of Galcanezumab. | All randomized participants who received at least one dose of study drug and had measurable serum concentrations. | Posted | Mean | Standard Deviation | Nanogram per milliliter (ng/mL) | Month 6 |
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| Secondary | Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) | Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP). | All randomized participants who had received at least one dose of study drug and had measurable plasma concentrations. | Posted | Mean | Standard Deviation | ng/mL | Month 6 |
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Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug.
SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo - Treatment Phase | Participants received placebo by subcutaneous injection once a month for 6 months. | 0 | 433 | 5 | 432 | 129 | 432 |
| EG001 | Galcanezumab 120mg - Treatment Phase | Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection. | 0 | 213 | 6 | 206 | 63 | 206 |
| EG002 | Galcanezumab 240mg - Treatment Phase | Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months. | 0 | 212 | 0 | 220 | 72 | 220 |
| EG003 | Placebo - Post-Treatment Phase | Participants didn't receive any intervention. | 0 | 372 | 2 | 372 | 22 | 372 |
| EG004 | Galcanezumab 120mg - Post-Treatment Phase | Participants didn't receive any intervention. | 0 | 185 | 4 | 183 | 12 | 183 |
| EG005 | Galcanezumab 240mg - Post-Treatment Phase | Participants didn't receive any intervention. | 0 | 183 | 4 | 185 | 12 | 185 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Inner ear disorder | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Incarcerated incisional hernia | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vertebral osteophyte | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Tonsil cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Tubular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA 20.0 | Systematic Assessment |
| |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA 20.0 | Systematic Assessment |
| |
| Adjustment disorder with mixed anxiety and depressed mood | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 25, 2017 | Oct 4, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000628360 | galcanezumab |
Not provided
Not provided
Not provided
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Puerto Rico |
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| United States |
|
| <.001 |
| Mean Difference (Final Values) |
| -1.76 |
| Standard Error of the Mean |
| 0.28 |
| 2-Sided |
| 95 |
| -2.31 |
| -1.20 |
| Superiority |
|
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|
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
| OG002 | Galcanezumab 240mg | Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months. |
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Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
|
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| Units | Counts |
|---|---|
| Participants |
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| OG002 | Galcanezumab 240mg | Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months. |
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